MAUDE Adverse Event Report: NULL; BREATHING CIRCUIT CIRCULATOR

Lot Number 210628

Device Problem Gas/Air Leak (2946)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2021

Event Type  malfunction  

Event Description

It was reported that during pre-test, leakage of air from the breathing circuit was detected.No patient injury.No additional information is available for this complaint.

Manufacturer Narrative

One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated, along with melting and dents on the circuit.Dhr review was done, no issues related to the original complaint were found.

• Type of Device: BREATHING CIRCUIT CIRCULATOR
• Manufacturer (Section G): NULL
• MDR Report Key: 12509765
• MDR Text Key: 272647973
• Report Number: 3012307300-2021-09510
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 210628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/21/2021
• Supplement Dates Manufacturer Received: 10/16/2021
• Supplement Dates FDA Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1